K152923 - BD ChloraShield IV Dressing with CHG Antimicrobial (FDA 510(k) Clearance)

K152923 is an FDA 510(k) clearance for the BD ChloraShield IV Dressing with CHG Antimicrobial. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on November 5, 2015 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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